Day 1 :
Keynote Forum
Abraham G. Hartzema
University of Florida, USA
Keynote: Strenghtening the Clinical Evidence provided by Observational Studies
Time : 10:15-11:15
Biography:
Abraham G Hartzema is a Professor and Eminent Scholar at the University of Florida in the Department of Pharmaceutical Outcomes & Policy. He is the Perry A Foote Chair in Health Outcomes Research and a Professor of Epidemiology and Biostatistics in the College of Public Health and the College of Medicine. In the year 2007, he was awarded the University of Florida Foundation Research award. He has widely published on various aspects of prescription drug safety, including several books on pharmacoepidemiology. He has served on the scientific board of the FIP from 1988-1996 and on Editorial Boards, including Medical Care, Annals of Pharmacotherapy, Clinical Therapeutics, the International Journal of Pharmacy Practice, Pulmonary Circulation and others. He has been the Chair of Data Safety and Monitoring Boards for several RTCs at the University of Florida. He has also served on the University of Florida Graduate Council and Grant Review Panels for AHRQ, FDA, HealthCanada, DSEN, NASA, NIH and NIHBL. He currently serves on the United States Pharmacopeia: Nomenclature, Safety and Labeling Expert Committee. He was recently appointed as a Senior Advisor to the FDA, Center for Devices and Radiological Health.
Abstract:
Why is the clinical evidence from observational studies in the literature often conflicting and delayed? We will address the efforts undertaken in the US FDA to provide more recent evidence on the safety of newly marketed drugs as mandated by US Congress. The Sentinel system is a distributed data system that allow for the time analysis of emerging drug safety questions. The automation of the safety queries and the large population covered (120 male patients), allows for the timely analysis and provide the statistical power to address safety question in the early uptake of drugs in the marketplace. The second important question is the often conflicting evidence presented in the literature. What is the source of this conflicting evidence? Our group has conducted significant research in the influence of biases, confounding and the interaction of statistical methods and structure and quality of data on the clinical evidence presented. Running statistical methods, including high dimensional propensity scores on 12 different databases we found that self-controlled designs, those observational designs in which the patient serves as its own control are the most powerful designs as these provide the opportunity to control for fixed confounders. These methods do not control for variable confounders and are most suitable when the outcomes follow immediately after drug exposure. Other issues considered are case identification in large databases and formulating search algorithm that have high PPVs to make sure that cases are indeed attributable to the exposure. Recent proposed methods include sensitivity analysis to test the robustness of the clinical evidence identified. Adherence to these practices will assure that the clinical evidence presented is valid and can be incorporated in practice guidelines
Keynote Forum
Swamy KB
Lincoln University College, Malayisa
Keynote: The latest trends of IQ and brain size and effects of life style and environmental factors on cranial capacity
Time : 11:35-12:35
Biography:
Swamy K B has been awarded PhD by Andhra University, his Master’s Degree MS (in Clinical Anatomy) from Andhra Medical College, D M C h (Maternal & Child Health) from IGNOU, New Delhi, his Medical Degree (MBBS) in 1976, from SV University, India. He has expertise in multi medical disciplines, Human Genetics, Reproductive Health & Developmental Anatomy and in Herbal Medicine. He has been the genetic counsellor for many Medical institutions. He possess prestigious grants FRGS,URGS from Malaysia, he has conducted researches on Herbal Medicine and Diabetes, “Brain size and Intelligence Quotient (IQ)”, He has been the former founder Anatomist, Professor and Head for many Medical Schools in India as well as in Malaysia. He is an International Editorial Board Member for many reputed journals like Anatomical Society of India (ASI). Recently he has been unanimously elected as an Executive Board Member for ASI .
Abstract:
Intelligence quotient (IQ) is widely used to assess different aspects of mental ability. Development in mental ability initiates from conception and continues through adulthood. Various environmental factors affect IQ. The aim of this study was to assess the correlation between IQ and environmental characteristics on cranial capacity in children and adolescents in Malaysia. This cross sectional study was performed on primary and secondary school students in Kuala Terengganu, Malaysia. Students, who were aged between 6 to 16 years and did not have any mental or physical disabilities, participated in this study. Measurements including weight, height, body mass index and cephalometry were performed for each subject. The Wechsler Abbreviated Scale for Intelligence- Second Edition (WASI-II) questionnaire was used for each subject to evaluate the subtests of IQ. A total of 419 subjects with the mean age of 12.51 ± 2.82 years had participated in this study. Boys were taller (p=0.04), had higher IQ (p=0.01) and cranial capacity (p<0.001) as well as block design score (p=0.02) when compared with girls. There was a significant mean effect for age (p=0.03), gender (p=0.04), paternal education (p=0.04), family income and block design (p=0.03) on cranial capacity. This study revealed different patterns of brain growth, function and IQ amongst male and female subjects as well as defining the environmental factors that can affect cranial capacity and that the IQ and cranial capacity may be improved by tuning up the lifestyles and economic conditions of the families in developing countries. (It is an original research conducted in Malaysia)